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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR101209
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 09/22/2020
Event Type  malfunction  
Event Description
It was reported that before a navio ukr procedure, there was an e6 error. The anspach drill was swapped out with its backup to proceed without delays. No patient was involved at the moment the issue was found and no other complications were reported.
 
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Brand NameANSPACH EMAX 2 PLUS HAND PIECE - ROHS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
7634524980
MDR Report Key10690512
MDR Text Key211686883
Report Number3010266064-2020-01874
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSR101209
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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